Status:
COMPLETED
Dermacyd in Odor Reducing.
Lead Sponsor:
Sanofi
Conditions:
Hygiene
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
Primary Objective: \- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegeta...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Perfect mucosa in the product analysis region
- Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory
- Bacterioscopy describing the vaginal flora
- Negative Trichomonas vaginalis test
- Negative Whiff test
- Willingness in using preservative in the sexual intercourse during the study period
- Use the same category cosmetics products
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion
- Exclusion criteria:
- Use of antiinflammatory / immunosuppression / antihistaminic drugs
- Atopic or allergy history to cosmetic products
- Active cutaneous disease (local and/or disseminated) in the evaluated area
- Disease which can cause immunosuppression, such as diabetes, HIV, etc.
- Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs
- Intense solar exposure (to get a tan) during the 15 days before the evaluation
- Gynecologic treatment until four weeks before the evaluation
- Any vaginal infection detected during the inclusion
- Other conditions considered by the investigator as reasonable for exclude the patient in the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT01158365
Start Date
July 1 2010
End Date
December 1 2010
Last Update
January 4 2011
Active Locations (1)
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1
Sanofi-Aventis Investigational Site Number 076-001
Osasco, Brazil, 06023-000